1. Field of the Invention
The present invention relates to a method utilizing a single administration or a unit dosage of omega-3 fatty acids and/or omega-3 fatty acid amides for the treatment of patients with dyslipidemias, including hypertriglyceridemia, high LDL-C serum levels, coronary heart disease (CHD), vascular disease, artherosclerotic disease, hypertension, and related conditions, and the prevention or reduction of cardiovascular and vascular events.
2. Description of Related Art
Cardiovascular diseases leading to morbidity and premature mortality are related to several risk factors such as hypertension, hypertriglyceridemia, hypercholesterolemia, high blood platelet aggregation and according to recent findings, a high activity of the blood coagulation factor VII phospholipid complex. Over the last four decades, antihypertensive drugs have contributed to the decline in cardiovascular disease-related morbidity and mortality. There is, however, heightened concern about side effects and toxicity associated with the current antihypertensive therapy, especially in the mildly hypertensive patient. There are results indicating that, although some antihypertensive agents are efficient in reducing blood pressure, the pulse rate is coincidentally increased. Thus, there is a need for a drug with fewer adverse effects for the treatment of hypertension. It would be particularly advantageous if such a drug could be used for the simultaneous treatment of all the above mentioned multiple risk factors associated with cardiovascular diseases, which is generally not the case with the currently available antihypertensive drugs.
During the late 1980s through the mid-1990s, numerous publications appeared which report that various dietary fish oil preparations containing omega-3 polyunsaturated fatty acids have the effect of lowering serum triglycerides and cholesterol.
There are currently over 40 different non-prescription, over-the-counter products containing omega-3 fatty acids, usually as triglycerides. In these formulations, the triglycerides are polydisperse, containing both saturated as well as unsaturated fatty acids. For example, flax seed oil has a typical composition as follows:
PolyMonounsaturatedSaturatedunsaturatedAlphaCapricLauricMyristicPalmiticStearicOleicLinoleicLinolenicUnsat./Sat.AcidAcidAcidAcidAcidAcidAcid (ω6)Acid (ω3)Oil or FatratioC10:0C12:0C14:0C16:0C18:0C18:1C18:2C18:3Flaxseed Oil9.0———37211653In some cases the saturated fatty acids can interfere with the effects of the polyunsaturated omega-3 fatty acids.
U.S. Pat. Nos. 5,502,077 and 5,656,667, both to Breivik et al., describe a lipid-regulating agent, as a liquid-filled gel capsule for oral administration. Each 1-gram capsule of this formulation, which is commercialized as Lovaza® (GSK, Research Triangle Park, N.C. 27709), contains at least 900 mg of the ethyl esters of omega-3 fatty acids. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA—approximately 465 mg) and docosahexaenoic acid (DHA—approximately 375 mg).
In patients with very high triglyceride levels (>500 mg/dL) Lovaza is reported to lower triglyceride levels 44.9% [Lovaza Package Insert, Table 2]. Unfortunately this formulation adversely affects low density lipoprotein cholesterol (LDL-C), increasing it by 44.5%. Patients are at an increased risk of cardiovascular diseases and events when their LDL-C increases.
There is therefore a need to provide the beneficial effects of omega 3-fatty acids in compositions and formulations that do not have the LDL-C raising effects of the prior art formulations but in fact lower both LDL-C and triglycerides.